Wellbutrin and Wellbutrin SR (bupropion hydrochloride) Tablets, For Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –
April 2016
ADVERSE REACTIONS
Postmarketing Experience
…Parkinsonism…
March 2013
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Victoza (liraglutide) Injection, for Subcutaneous Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
ADVERSE REACTIONS
Inclusion of results from Trial NN2211-3916, which was a 26-week double-blind placebo-controlled,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Cancidas (caspofungin acetate) for Injection, for Intravenous Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
ADVERSE REACTIONS
Postmarketing Experience
… toxic epidermal necrolysis…Stevens-Johnson syndrome…
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Triumeq (abacavir, dolutegravir, and lamivudine) Tablets, For Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
ADVERSE REACTIONS
Clinical Trials Experience
Week 144 safety and efficacy data from Phase III study ING114467... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Tivicay (dolutegravir) Tablets, For Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
DRUG INTERACTIONS
Effect of Dolutegravir on the Pharmacokinetics of Other Agents
…daclatasvir…
ADVERSE... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Nplate (romiplostim) for Injection, for Subcutaneous Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
ADVERSE REACTIONS
Clinical Trials Experience
Bone Marrow Reticulin Formation and Collagen Fibrosis
Nplate... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Limbitrol (chlordiazepoxide and amitriptyline HCI) and Limbitrol DS
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
PRECAUTIONS
Drug-Drug Interactions
Topiramate
Some patients may experience a large increase in... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Cialis (tadalafil) Tablets, For Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
ADVERSE REACTIONS
…Peripheral edema…diarrhea
USE IN SPECIFIC POPULATIONS
Geriatric Use
Of... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Zonegran (zonisamide) Capsules, for Oral Administration
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Drug... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension, Vibramycin Hyclate (doxycycline hyclate capsules, USP), Vibramycin Calcium (doxycycline calcium oral suspension) Syrup, Vibra-Tabs (doxycycline hyclate tablets, USP)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
Summary View
WARNINGS
Use doxycycline in pediatric patients 8 years of age or less only when the potential benefits... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Precedex (dexmedetomidine hydrochloride) Injection and Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
Hypotension, Bradycardia, and Sinus Arrest
Some of these cases have resulted in fatalities.
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Oxaliplatin Injection for Intravenous Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
Severe Neutropenia
Grade 3 or 4 neutropenia occurred in 41 to 44% of patients with... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Onglyza (saxagliptin) Tablets, for Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
Pancreatitis
There have been postmarketing reports of acute pancreatitis in patients... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Nesina (alogliptin) Tablets, for Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
Pancreatitis
Acute pancreatitis has been reported in the postmarketing setting and in... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Lenvima (lenvatinib) Capsules, for Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
Hemorrhagic Events
Serious tumor related bleeds, including fatal hemorrhagic events... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
